BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERNA UNIVERSAL PLUS PLATFORM IMPLANT CA

    MDR report key: 19793145 · Received July 22, 2024

    Report

    Report Number
    3004417597-2024-00038
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    August 21, 2021
    Manufacturer
    B.T.I. BIOTECHNOLOGY INSTITUTE S.L.
    Product Code
    DZE
    UDI-DI
    08435389811893
    PMA / PMN Number
    K151391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH DOCUMENTATION IS CHECKED AND NO ANOMALIES ARE DETECTED. ANY MANUFACTURING FAULT IS RULED OUT. AFTER EXAMINATION OF THE IMPLANT, IT CAN BE VERIFIED THAT THE IMPLANT DOES NOT SHOW SIGNS OF MISUSE OR SIGNS OF MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE EVENT. HOWEVER, THERE IS A SMALL GAP BETWEEN THE HEALING CAP AND THE TRANSEPITHELIAL ABUTMENT, AS WELL AS SIGNS OF INFECTION AROUND THIS AREA.

    Description of Event or Problem · 0

    THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2021 AND ONE MONTHS LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY II. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119357 INTERNA UNIVERSAL PLUS PLATFORM IMPLANT CA DZE B.T.I. BIOTECHNOLOGY INSTITUTE S.L. IIPSCA5065 BA00190.Z 08435389811893

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention